FDA explores single-dose packaging to reduce opioids abuse

January 30, 2018

Silver Spring, Md. — In an effort to curb the prescription opioids abuse epidemic, the Food and Drug Administration on Jan. 30 announced it is looking to change how manufacturers package their products so that health care providers can have better options for prescribing opioids.

“We believe one of our key roles in addressing the opioid epidemic is to reduce new addiction,” said FDA Commissioner Scott Gottlieb, M.D., during a stakeholder meeting convened to seek feedback on how the agency can strengthen its oversight. “We’re exploring ways we can reduce exposure to opioids through our influence on prescribers, particularly through our Risk Evaluation and Mitigation Strategy authorities. We’re also actively exploring how we can use changes in packaging as a way to give providers better options for tailoring how much they prescribe to the clinical need. This is especially true when it comes to immediate release formulations of opioid drugs like Vicodin and Percocet, which are typically meant for short-term use.”

Dr. Gottlieb said single-dose packaging could also be beneficial for patients in dental settings. For instance, patients who may need pain relief immediately after a dental procedure could receive prescriptions limited to a three or five-day initial fill of immediate-release opioids such as Vicodin and Percocet.

“If the FDA reviewed and determined that blister packs in these quantities were necessary to ensure safe use,” Dr. Gottlieb said, and “if the drugs were then packaged in blister packs that comported with these durations of use, it could help reduce overall dispensing. More doctors might more readily opt to prescribe these blister packs instead of other treatment options.”